Prediction of bladder cancer disease course using risk scores that combine molecular and clinical risk factors
- a FP7 project partly financed by the European Commission. It started on February 1, 2008 and ends in January 2013

top row - left: F. Real, Victor, W. Beukers, S. Tjin, E. Steyerberg, T.F. Ørntoft, L. Dyrskjøt, C.B. Pedersen, N. Malats
bottom row - left: E. Zwarthoff, F. Algaba, P.U. Malmström, U. Segersten, M.L. Calle

Bladder cancer is a recurrent and very prevalent cancer in the EU and this tumor generates the highest cost per patient in Europe. About one in 1500 people is under surveillance for possible bladder cancer recurrences. New genomic methods have allowed identifying new markers with potential clinical application. Genetic mutations, expression profiles, and microsatellite alterations in tumor tissue and urine, as well as polymorphisms in immune response genes, are very promising biomarkers that predict a tumor being present in the bladder and its likelihood of progression to invade the muscle. In the UROMOL project we will combine the best markers for bladder cancer detection and outcome in a prospective multicenter validation study. To achieve enough power to rapidly generate conclusive results, 2000 patients will consecutively be enrolled, and subjected to analysis. The approach is a pre-defined, standard operating procedure based, prospective study with fixed end-points and testing relatively few independent variables on tumor tissue, urine and blood. Successfully validated biomarkers will lead to specific recommendations for changes in patient management based on the risk scores. We estimate saving of more than 40 mill Euros annually based on a reduced frequency of cystoscopies, as well as an increased survival and a better quality of life for the patients. The project will be carried out with the highest possible ethical standards, complying with all EU and national regulations.